LEGIONELLA CULTURE CONFIRMATIN KIT

FDA 510(k)

FDA Class 2 ·Microbiology

MP TEST

FDA 510(k)

FDA Class 1 ·Microbiology

THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.

FDA 510(k)

FDA Class 1 ·Microbiology

MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

DIAGNOSTIC REAGENT SET-RPLA

FDA 510(k)

FDA Class 1 ·Microbiology

FLUORESCENT ANTIBODY CONJUGATE FOR GP.A

FDA 510(k)

FDA Class 1 ·Microbiology

STAPHAUREX ZL30

FDA 510(k)

FDA Class 1 ·Microbiology

MYCOPLASMA IGM ELISA TEST SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM

FDA 510(k)

FDA Class 1 ·Microbiology

STREP B POLYVALENT FLUORO-KIT

FDA 510(k)

FDA Class 1 ·Microbiology

BACTOGEN-H. INFLUENZAE TYPE B

FDA 510(k)

FDA Class 2 ·Microbiology

MYCOPLASMELISA TEST KIT

FDA 510(k)

FDA Class 1 ·Microbiology

PHADEBACT HAEMOPHILUS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed® Infusion System, Ascenda® Intrathecal Catheters

Advanced LumFix Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid

FDA 510(k)

FDA Class 2 ·Dental

SEJONG Surgical Gown Soft

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Model A219 EMBLEM MRI S-ICD Pulse Generator; Model A209 EMBLEM S-ICD Pulse Generator; Model 2877 Programmer Software App

dermanostic App

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Dermanostic GmbH·3 devices

iBreathe APP

Basic UDI-DI

EU MDR · Eu Md Class 1 ·FEELLIFE HEALTH INC.·1 device